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Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer

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ClinicalTrials.gov Identifier: NCT01737216
Recruitment Status : Unknown
Verified November 2012 by Hebei Tumor Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : December 31, 2012
Sponsor:
Information provided by (Responsible Party):
Hebei Tumor Hospital

Brief Summary:
Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Zoledronic acid plus EP/TP Drug: EP/TP Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2012
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Zoledronic acid plus First-line chemotherapy Drug: Zoledronic acid plus EP/TP
Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression
Active Comparator: First-line chemotherapy Drug: EP/TP
Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles
Other Name: First-line chemotherapy



Primary Outcome Measures :
  1. Progression-free survival(PFS) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: 3 years ]
  2. Bone mineral density(BMD) [ Time Frame: 1 year ]
  3. Quality of life(QOL) [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form
  • Age ≥70 years
  • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  • Histologically or cytologically confirmed lung cancer
  • Did not receive bisphosphonate treatment

Exclusion Criteria:

  • Appear relapse and metastasis
  • receive other bisphosphonate treatment
  • Active or uncontrolled infection
  • Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737216


Locations
China, Hebei
Hebei Tumor Hospital
Shijiazhuang, Hebei, China, 050011
Sponsors and Collaborators
Hebei Tumor Hospital
Investigators
Principal Investigator: Wei Liu Hebei Tumor Hospital

Responsible Party: Hebei Tumor Hospital
ClinicalTrials.gov Identifier: NCT01737216     History of Changes
Other Study ID Numbers: HBTH201
Hebei Tumor Hospital ( Registry Identifier: Hebei Tumor Hospital )
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: December 31, 2012
Last Verified: November 2012

Keywords provided by Hebei Tumor Hospital:
Aged
patients

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs